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Expert perspectives focused on the latest bioanalytical topic & trends

Bioanalytical Support for Gene Therapy Programs

An Introduction to Gene Therapy: As early as the 1970’s, the term “gene therapy” was used for the treatment of genetic disorders at the DNA level to replace the defective or missing proteins driving disease. By introducing functional gene copies to patients’ cells, the subsequent in vivo expression of protein leads to a therapeutic effect and may ultimately cure the associated disorder. Gene therapy has undergone several major paradigm shifts

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How Have Advanced Drug Modalities Impacted Bioanalysis?

As therapeutic drugs have grown in complexity, so too have the bioanalysis techniques to support these products. Bioanalysis of small molecule drugs has become more routine over time with the accumulation of experience gained through decades of work. The advent of large molecule therapeutics ushered in all new challenges as protein-based immunoassays became the norm. These assays tend to be less robust than those used for small molecule work and more variable due

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